To place your pharmaceutical, biotech of advanced therapy on the US market you must first gain FDA regulatory approval. Like all regulatory agencies, the FDA process requires skill and knowledge to navigate efficiently and to ensure fast approval.
This FDA regulatory training course examines the processes, terminology and best practices to ensure your interactions with the FDA are positive. Once completed, you will have the confidence to successfully submit Investigational New Drug Applications (IND) and New Drug Applications (NDA). You will learn the practical regulatory skills to get your pharmaceutical or biotech approved by FDA reviewers. You will also learn how best to gain approval for generics and biosimilars.